Phase I/II study of intermittent erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer

Phase 1

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-UMIN000001780
• Lead Sponsor: West Japan Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-17
• Study Completion: 2017-04-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Phase1 1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase 2)Previously received docetaxel 3)Obvious pulmonary interstitial abnormality on chest CT 4)Uncontrolled infections or uncontrolled serious systematic disease 5)symptomatic brain metastasis 6)Other co-existing malignancies or malignancies diagnosed within the last 5 years 7)significant pleural effusion, pericardial effusions or ascites, 8)patient who cannot eat enough 9)severe drug allergies 10)Hypersensitive to polysorbate80 11)Pregnant or breast feeding 12)HBs-Ag positive or HCV-Ab positive 13)Patient for whom this clinical trial is judged to be inappropriate by physicians Phase2 1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase 2)Previously received docetaxel 3)Obvious pulmonary interstitial abnormality on chest CT 4)Uncontrolled significant active infections or uncontrolled systematic disease 5)symptomatic brain metastasis 6)Other co-existing malignancies or malignancies diagnosed within the last 5 years 7)significant pleural effusion, pericardial effusions or ascites, 8)patient who cannot eat enough 9)severe drug allergies 10)Hypersensitive to polysorbate80 11)Pregnant or breast feeding 12)HBs-Ag positive or HCV-Ab positive 13)Patient for whom this clinical trial is judged to be inappropriate by physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified